Calamine Lotion 063.001'063AA

Manufacturer: Perrigo Direct, Inc. | Vi Jon, LLC
Effective date: 2022-09-19
Label type: HUMAN OTC DRUG LABEL
Version: 14
Source: legacy-cache
Hydrated at: 2026-08-01 21:53:26

Label at a glance#

ProductCalamine

Active ingredientFERRIC OXIDE RED, ZINC OXIDE

Label structure12 sections

Dosage and administration

• shake well before using • apply as needed

Storage and handling

store at 59⁰ - 86⁰ F

Contacts and useful links#

PhoneLabel contact1-866-593-0593

Websitewww.perrigodirect.com

www.PerrigoDirect.com

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Calamine 8%
Zinc oxide 8%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Use

INDICATIONS & USAGE SECTION

dries the oozing and weeping of poison:•ivy • oak • sumac

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

Do not get into eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

condition worsens
symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

• shake well before using • apply as needed

Other information

STORAGE AND HANDLING SECTION

store at 59⁰ - 86⁰ F

Inactive ingredients

INACTIVE INGREDIENT SECTION

bentonite magma, calcium hydroxide, glycerin, purified water

SPL UNCLASSIFIED SECTION

Distributed by: Perrigo Direct, Inc

Peachtree City, GA 30269

www.PerrigoDirect.com

1-866-593-0593

GoodSense is a registered trademark of L. Perrigo Company.

principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GOODSENSE

NDC 75981-063-30

Calamine Lotion

Calamine Topical Suspension USP

Skin Protectant

Poison Ivy, Oak, Sumac, Drying Lotion

6 FL OZ (177 mL)

image description

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

Calamine
FERRIC OXIDE RED
ZINC OXIDE
BENTONITE
CALCIUM HYDROXIDE
GLYCERIN
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
50804-063	50804-063-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
FERRIC OXIDE RED	1K09F3G675	ACTIB
ZINC OXIDE	SOI2LOH54Z	ACTIB
BENTONITE	A3N5ZCN45C	IACT
CALCIUM HYDROXIDE	PF5DZW74VN	IACT
GLYCERIN	PDC6A3C0OX	IACT
WATER	059QF0KO0R	IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
518d6789-2e89-447b-9168-ac825832086c			63f45b6a-115e-45f6-ad5c-0ef20623763e	2023-10-16	Warnings	Exact identifier spl set id: 63f45b6a-115e-45f6-ad5c-0ef20623763e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.